Tag Archives: Health Canada

Deadline extension (travel grants and poster abstracts) for alternate testing strategies (ATS) of nanomaterials workshop

It seems there have been a couple of deadline extensions (to August 1, 2014) for the September 15-16, 2014 ‘Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials’ in Washington, DC (first mentioned in my July 10, 2014 posting featuring a description of the workshop). You can go here to submit a poster abstract (from any country) and you can go here if you’re a student or young professional (from any country) in search of a $500 travel award.

I managed to speak to one of the organizers, Lorraine Sheremeta, (Assistant Director, Ingenuity Lab, University of Alberta and co-author a July 9, 2014 Nanowerk Spotlight article about the workshop). Lorraine (Lori) kindly spoke to me about the upcoming workshop, which she described as an academic conference,.

As I understand what she told me, the hosts for the September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC want to attract a multidisciplinary group of people to grapple with a few questions. First, they want to establish a framework for establishing which are the best test methods for nanomaterials. Second, they are trying to move away from animal testing and want to establish which methods are equal to or better than animal testing. Thirdly, they want to discuss what they are going to do with the toxicological data  that we have  been collecting on nanomaterials for years now.

Or, as she and her colleague from the Society of Risk Analysis (Jo Anne Shatkin) have put in it in their Nanowerk Spotlight article:

… develop a report on the State of the Science for ATS for nanomaterials, catalogue of existing and emerging ATS [alternate testing strategies] methods in a database; and develop a case study to inform workshop deliberations and expert recommendations

The collaborative team behind this event includes, the University of Alberta’s Ingenuity Lab, the Society for Risk Analysis, Environment Canada, Health Canada, and the Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) .

The speaker lineup isn’t settled at this time although they have confirmed Vicki Stone of Heriot-Watt University in Scotland (from her university bio page),

Vicki Stone, Professor of Toxicology, studies the effects of nanomaterials on humans and environmentally relevant species.  Current research projects investigate the mechanism of toxicity of a range of nanomaterials in cells of the immune system (macrophages and neutrophils), liver (hepatocytes) , gastrointestinal tract, blood vessels (endothelium) and lung.  She is interested in interactions between nanomaterials, proteins and lipids, and how this influences subsequent toxicity.  Current projects also develop in vitro alternatives using microfluidics as well as high resolution imaging of individual nanomaterials in 3D and over time.  In addition Vicki collaborates with ecotoxicologists to investigate the impacts of nanomaterials on aquatic organisms. Vicki coordinated a European project to identify the research priorities to develop an intelligent testing strategy for nanomaterials (www.its-nano.eu).

Vicki is Director of the Nano Safety Research Group at Heriot-Watt University, Edinburgh, and Director of Toxicology for SAFENANO (www.safenano.org). She has acted as the Editor-in-chief of the journal Nanotoxicology (http://informahealthcare.com/nan) for 6 years (2006-2011). Vicki has also published over 130 publications pertaining to particle toxicology over the last 16 years and has provided evidence for the government commissioned reports published by the Royal Society (2003) and the on Environmental Pollution (2008).  Vicki was previously a member of the UK Government Committee on the Medical Effects of Air Pollution (COMEAP) and an advisory board member for the Center for the Environmental Implications of NanoTechnology (CEINT; funded by the US Environmental Protection Agency)).

A representative from PETA (People for the Ethical Treatment of Animals) will also be speaking. I believe that will be Amy Clippinger (from the PETA website’s Regulatory Testing webpage; scroll down about 70% of the way),

Science adviser Amy Clippinger has a Ph.D. in cellular and molecular biology and genetics and several years of research experience at the University of Pennsylvania.

PETA representatives have been to at least one other conference on the topic of nano, toxicology, and animal testing as per my April 24, 2014 posting about NANOTOX 2014 in Turkey,

Writing about nanotechnology can lead you in many different directions such as the news about PETA (People for the Ethical Treatment of Animals) and its poster presentation at the NanoTox 2014 conference being held in Antalya, Turkey from April 23 – 26, 2014. From the April 22, 2014 PETA news release on EurekAlert,

PETA International Science Consortium Ltd.’s nanotechnology expert will present a poster titled “A tiered-testing strategy for nanomaterial hazard assessment” at the 7th International Nanotoxicology Congress [NanoTox 2014] to be held April 23-26, 2014, in Antalya, Turkey.

Dr. Monita Sharma will outline a strategy consistent with the 2007 report from the US National Academy of Sciences, “Toxicity Testing in the 21st Century: A Vision and a Strategy,” which recommends use of non-animal methods involving human cells and cell lines for mechanistic pathway–based toxicity studies.

There is a lot of interest internationally in improving how we test for toxicity of nanomaterials. As well, the drive to eliminate or minimize as much as possible the use of animals in testing seems to be gaining momentum.

Good luck to everyone submitting a poster abstract and/or an application for a travel grant!

In case you don’t want to scroll up, the SRA nano workshop website is here.

Canada-US joint Regulatory Cooperation Council nanotechnology initiative completed and Canada endorses OECD nanomaterials recommendation

Thanks to Lynn Bergeson’s July 9, 2014 posting on Nanotechnology Now, I learned the Canada-US joint Regulatory Cooperation Council (RCC) nanotechnology initiative has completed its work and will be filing final reports later this summer (2014).

I have featured the RCC here in at least three postings, a Dec. 3, 2012 posting, a June 26, 2013 posting, and a January 21, 2014 posting. Briefly, the RCC was first announced in 2011 and is intended to harmonize Canadian and US regulatory frameworks in a number of areas including, agriculture and food, transportation, personal care products and pharmaceuticals and more. Significantly, nanotechnology was also part of their portfolio.

The latest information about RCC doings was obtained from the Canadian government’s 2014 summer issue of the Chemicals Management Plan (CMP) Progress Report (a second thank you for Bergeson for information about this publication),

The Canada-U.S. Regulatory Cooperation Council Nanotechnology Initiative is now complete. Canada and the U.S. are implementing the new approaches and lessons learned in risk assessments of nanomaterials. An important outcome of the initiative is the development of consistent policy principles on the regulatory oversight of nanomaterials, which have now been endorsed by the Government of Canada. Watch for the publication of the final reports from the Canada-U.S. Regulatory Cooperation Council Nanotechnology Initiative this summer. The reports will include recommendations about ways in which Canada and the U.S. can align their nanomaterial regulatory work, including the application of consistent risk assessment approaches and methodologies and identifying categories of nanomaterials.

The 2014 CMP summer issue offers a second tidbit of information. This time it’s about Canada and the OECD,

Canada has endorsed a recommendation from the Organisation for Economic Co-operation and Development’s Council on the Safety Testing and Assessment of Manufactured Nanomaterials. The recommendation states that countries “apply the existing international and national chemical regulatory frameworks or other management systems, adapted to take into account the specific properties of manufactured nanomaterials.” The recommendation was based on the work of the Organisation for Economic Co-operation and Development’s Working Party on Manufactured Nanomaterials, which is a harmonization effort to inform regulatory programs regarding the environmental and health and safety implications of manufactured nanomaterials.

For enthusiasts, Canada’s Chemicals Management Plan progress report is expected to be published twice/year. There are now two issues available, the first with a Dec. 30, 2013 publication date. Here’s more about the CMP progress reports,

The Chemicals Management Plan Progress Report has been created to keep stakeholders and other interested parties up to date on the activities and programs related to Canada’s Chemicals Management Plan (CMP). The report is produced jointly by Environment Canada and Health Canada and will be published twice a year. It will report on advances in major initiatives and highlight key activities related to the Government of Canada’s recent work under the CMP. It will also inform you about coming events, dates of interest and how to get involved.

We encourage you to share the reports with anyone who may be interested. We also welcome your feedback or suggestions. We can be reached at [email protected]

Anyone interested in more information about the RCC (Regulatory Cooperation Council) and its nanotechnology efforts can find it here.

An upcoming alternate testing strategies (ATS) for nanomaterials workshop and the quest to reduce animal testing

It’s too late to announce a call for poster abstracts or travel awards but that still leaves the possibility of attending a September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC. In a July 9, 2014 Nanowerk Spotlight article,, Jo Anne Shatkin (President, Vireo Advisors) and Lorraine Sheremeta (Assistant Director, Ingenuity Lab, University of Alberta) tout the workshop in the context of describing new approaches to nanotoxicology research (Note: A link has been removed),

Engineered nanoscale materials (ENM or ‘nanomaterials’) offer the potential to create safer and more effective products through the use of smaller quantities of improved performance materials. Currently nanomaterials are used to improve the performance of life-saving drugs and medical technologies, to make renewable energy more efficient, to make value added products from industrial waste streams, to improve food, packaging, to lightweight materials used in transportation systems, and to improve many of the personal care products that we use every day. Nanomaterial manufacture and use is expected to increase over the coming years and despite the widespread use of nanomaterials in a variety of consumer products, we are only beginning to understand the impacts of these emerging materials on our health and the environment. To this end, the University of Alberta’s Ingenuity Lab is collaborating with the Society for Risk Analysis to evaluate the potential to use alternative test strategies (ATS) to improve our ability to assess nanomaterial toxicity and environmental impact.

Shatkin and Sheremeta describe toxicology tests and explain the importance of refining and improving these tests (from the article),

Standard in vivo toxicology test methods that depend heavily on the use of animals have long been used to assess chemical safety. [emphasis mine*] Existing and novel in vitro and in silico test methods provide important alternatives to in vivo animal testing for chemicals and potentially for ENM. Genotoxicity tests, for example, are used to assess the mutagenic potential of chemicals or nanomaterials in the replication of DNA in cells. Driven in part by increasing market and regulatory requirements for safer and more sustainable products, large international infrastructure has developed for creating, testing and validating in vitro test methods, and its use is expanding to chemical and nanomaterial assessment (NSF, 2007). The goals of reducing, refining and replacing animal testing (the commonly cited ‘three Rs’) – resonate with key and diverse stakeholders including animal rights groups, the bioethics community, the pharmaceutical industry, regulatory agencies and the broader public. [emphasis mine*]

Despite nearly a decade of effort in the conduct toxicology and exposure research to inform the assessment of health and environmental risks of nanomaterials, major gaps remain in the ability to understand and quantify risks. While there is now a large body of published data on carbon nanotubes and metal oxide nanoparticles, concern has been raised that speculation about nanomaterial risk has hardened into an assumption that there are ‘as-yet-to-be-discovered risks’ that we must identify and manage (Maynard, 2014) that demands extensive testing.

The authors describe ATS (alternative test strategies) in greater detail,

ATS approaches are regarded by many to have the potential for rapid screening of large numbers and types of materials. They can include a breadth of techniques including high throughput screening methods (HTS), high content screening, computational approaches, toxicogenomics, cell-based methods, in vitro assays and non-mammalian whole animal models. The emergence of ATS raises questions about how the results of these methods may be used for assessing the potential risks of ENM. For instance, ATS could be used in combination in a multiple models approach to evaluate new ENM in a number of rapid assays and compare with well-studied substances using in vivo testing; thereby identifying ENM for additional testing in a more strategic fashion than is possible through conventional testing approaches.

They also describe the current state of affairs with ATS,

In the United States, the U.S. ToxCast program has, as part of their 21st century toxicity screening program (NRC, 2007), tested 29 NMs with 62 in vitro test methods (Wang et al. 2013). Many researchers, including several from the University of Alberta, have proposed and developed ATS to include a variety of methods, some which are standardized for chemicals, and others which take advantage of developments including advanced biological mechanistic understanding, genomics, metabolomics, automation and informatics. However, these existing as well as emerging ATS have a short history with nanomaterials, and have not yet proven to be reliable for quantitative estimation of ENM risk. Still, several international efforts have developed ATS that have potential to be used for screening purposes, and to guide further testing priorities for regulatory decision making. The goal of the September [2014] workshop by the Society for Risk Analysis is to explore ways in which distinct ATS may be used for screening and prioritizing the need for more extensive testing of novel ENM.

The parties (including the authors of the article) involved in developing this risk workshop are listed, also mentioned are members of the international testing scene,

Lori Sheremeta, the Assistant Director of Ingenuity Lab in Edmonton Alberta and past Chair of the Society for Risk Analysis (SRA) Emerging Nanoscale Materials Specialty Group (ENMSG), is collaborating with U.S.-based nanomaterials risk expert Jo Anne Shatkin (an SRA Councilor and co-founder of the SRA ENMSG), Environment Canada, Health Canada, the SRA ENMSG and others on a Pilot Project with the Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) to develop a report on the State of the Science for ATS for nanomaterials, catalogue of existing and emerging ATS methods in a database; and develop a case study to inform workshop deliberations and expert recommendations.

There are many international efforts to develop, as well as to validate and standardize, these methods for chemicals, including organizations such as the US National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (ICCVAM), the European Union Reference Laboratory European Centre for the Validation of Alternative Methods (EURL ECVAM), the Japanese Center for the Validation of Alternative Methods (JacVAM), the Korean Centre for the Validation of Alternative Methods (KoCVAM) and the OECD. There is wide recognition that the diversity of NMs renders it impractical to use traditional animal testing to evaluate safety, hence there is significant interest in assessing the performance of both existing and emerging alternative testing strategies for NMs. Further, the EU directive REACH (Directive 2006/121/EC) requires replacing in vivo testing, and there is widespread popular agreement about the desire to limit animal testing. Finally, there is a need for more biologically informative toxicology methods (Hartung, 2010; Silbergeld et al, 2011; Landsiedel et al, 2009).

A list of the workshop objectives is offered  in the article,

The main objectives of the workshop are to:

assess the state of the science on HTS and ATS from a ‘multiple models’ perspective to identify areas of common findings from differing approaches, areas of greatest uncertainty, and priorities for follow up in applied research toward risk assessment of ENM;
evaluate the ability to use data from ATS/HTS methods for screening purposes – combining suites of assays and comparing well-studied substances to novel ones;

assess the ability to use a suite of ATS methods to amplify the Weight of Evidence;

characterize uncertainty associated with predictive relationships and propose strategies to address uncertainties;

elicit the perspectives of diverse stakeholders about the use of HTS/ATS for screening purposes in risk analysis of ENM; and

develop a set of recommendations for these alternative approaches to become more widely adopted for environmental, health and safety decision making about ENM across the product life cycle. The output of the workshop holds potential for transformation through risk screening approaches that promote safer and more sustainable material and technology development.

You can find more about the September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC here.

The text in the article is a bit rough. Some of the ideas and topics don’t follow each other logically. So, be prepared to spend a little time reading, Happily, there are references included with the article.

I last mentioned Jo Anne Shatkin here in the context of a 2013 paper on alternative test strategies (ATS) in an Aug. 22, 2013 posting. I think the most recent mention of Lorraine Sheremeta here is in a Jan. 11, 2010 posting about Canada, nanotechnology, and food.

Final note, I am hoping to get some more information about the workshop and ATS scene from Lorraine Sheremeta to be published in a subsequent posting.

* I added the emphases at 0830 hours PDT July 10, 2014.

Does digitizing material mean it’s safe? A tale of Canada’s Fisheries and Oceans scientific libraries

As has been noted elsewhere the federal government of Canada has shut down a number of Fisheries and Oceans Canada libraries in a cost-saving exercise. The government is hoping to save some $440,000 in the 2014-15 fiscal year by digitizing, consolidating, and discarding the libraries and their holdings.

One would imagine that this is being done in a measured, thoughtful fashion but one would be wrong.

Andrew Nikiforuk in a December 23, 2013 article for The Tyee wrote one of the first articles about the closure of the fisheries libraries,

Scientists say the closure of some of the world’s finest fishery, ocean and environmental libraries by the Harper government has been so chaotic that irreplaceable collections of intellectual capital built by Canadian taxpayers for future generations has been lost forever.

Glyn Moody in a Jan. 7, 2014 post on Techdirt noted this,

What’s strange is that even though the rationale for this mass destruction is apparently in order to reduce costs, opportunities to sell off more valuable items have been ignored. A scientist is quoted as follows:

“Hundreds of bound journals, technical reports and texts still on the shelves, presumably meant for the garbage or shredding. I saw one famous monograph on zooplankton, which would probably fetch a pretty penny at a used science bookstore… anybody could go in and help themselves, with no record kept of who got what.”

Gloria Galloway in a Jan. 7, 2014 article for the Globe and Mail adds more details about what has been lost,

Peter Wells, an adjunct professor and senior research fellow at the International Ocean Institute at Dalhousie University in Halifax, said it is not surprising few members of the public used the libraries. But “the public benefits by the researchers and the different research labs being able to access the information,” he said.

Scientists say it is true that most modern research is done online.

But much of the material in the DFO libraries was not available digitally, Dr. Wells said, adding that some of it had great historical value. And some was data from decades ago that researchers use to determine how lakes and rivers have changed.

“I see this situation as a national tragedy, done under the pretext of cost savings, which, when examined closely, will prove to be a false motive,” Dr. Wells said. “A modern democratic society should value its information resources, not reduce, or worse, trash them.”

Dr. Ayles [Burton Ayles, a former DFO regional director and the former director of science for the Freshwater Institute in Winnipeg] said the Freshwater Institute had reports from the 1880s and some that were available nowhere else. “There was a whole core people who used that library on a regular basis,” he said.

Dr. Ayles pointed to a collection of three-ringed binders, occupying seven metres of shelf space, that contained the data collected during a study in the 1960s and 1970s of the proposed Mackenzie Valley pipeline. For a similar study in the early years of this century, he said, “scientists could go back to that information and say, ‘What was the baseline 30 years ago? What was there then and what is there now?’ ”

When asked how much of the discarded information has been digitized, the government did not provide an answer, but said the process continues.

Today, Margo McDiarmid’s Jan. 30, 2014 article for the Canadian Broadcasting Corporation (CBC) news online further explores digitization of the holdings,

Fisheries and Oceans is closing seven of its 11 libraries by 2015. It’s hoping to save more than $443,000 in 2014-15 by consolidating its collections into four remaining libraries.

Shea [Fisheries and Oceans Minister Gail Shea] told CBC News in a statement Jan. 6 that all copyrighted material has been digitized and the rest of the collection will be soon. The government says that putting material online is a more efficient way of handling it.

But documents from her office show there’s no way of really knowing that is happening.

“The Department of Fisheries and Oceans’ systems do not enable us to determine the number of items digitized by location and collection,” says the response by the minister’s office to MacAulay’s inquiry. [emphasis mine]

The documents also that show the department had to figure out what to do with 242,207 books and research documents from the libraries being closed. It kept 158,140 items and offered the remaining 84,067 to libraries outside the federal government.

Shea’s office told CBC that the books were also “offered to the general public and recycled in a ‘green fashion’ if there were no takers.”

The fate of thousands of books appears to be “unknown,” although the documents’ numbers show 160 items from the Maurice Lamontagne Library in Mont Jolie, Que., were “discarded.”  A Radio-Canada story in June about the library showed piles of volumes in dumpsters.

And the numbers prove a lot more material was tossed out. The bill to discard material from four of the seven libraries totals $22,816.76

Leaving aside the issue of whether or not rare books were given away or put in dumpsters, It’s not confidence-building when the government minister can’t offer information about which books have been digitized and where they might located online.

Interestingly,  Fisheries and Oceans is not the only department/ministry shutting down libraries (from McDiarmid’s CBC article),

Fisheries and Oceans is just one of the 14 federal departments, including Health Canada and Environment Canada, that have been shutting physical libraries and digitizing or consolidating the material into closed central book vaults.

I was unaware of the problems with Health Canada’s libraries but Laura Payton’s and Max Paris’ Jan. 20, 2014 article for CBC news online certainly raised my eyebrows,

Health Canada scientists are so concerned about losing access to their research library that they’re finding workarounds, with one squirrelling away journals and books in his basement for colleagues to consult, says a report obtained by CBC News.

The draft report from a consultant hired by the department warned it not to close its library, but the report was rejected as flawed and the advice went unheeded.

Before the main library closed, the inter-library loan functions were outsourced to a private company called Infotrieve, the consultant wrote in a report ordered by the department. The library’s physical collection was moved to the National Science Library on the Ottawa campus of the National Research Council last year.

“Staff requests have dropped 90 per cent over in-house service levels prior to the outsource. This statistic has been heralded as a cost savings by senior HC [Health Canada] management,” the report said.

“However, HC scientists have repeatedly said during the interview process that the decrease is because the information has become inaccessible — either it cannot arrive in due time, or it is unaffordable due to the fee structure in place.”

….

The report noted the workarounds scientists used to overcome their access problems.

Mueller [Dr. Rudi Mueller, who left the department in 2012] used his contacts in industry for scientific literature. He also went to university libraries where he had a faculty connection.

The report said Health Canada scientists sometimes use the library cards of university students in co-operative programs at the department.

Unsanctioned libraries have been created by science staff.

“One group moved its 250 feet of published materials to an employee’s basement. When you need a book, you email ‘Fred,’ and ‘Fred’ brings the book in with him the next day,” the consultant wrote in his report.

“I think it’s part of being a scientist. You find a way around the problems,” Mueller told CBC News.

Unsanctioned, underground libraries aside, the assumption that digitizing documents and books ensures access is false.  Glyn Moody in a Nov. 12, 2013 article for Techdirt gives a chastening example of how vulnerable our digital memories are,

The Internet Archive is the world’s online memory, holding the only copies of many historic (and not-so-historic) Web pages that have long disappeared from the Web itself.

Bad news:

This morning at about 3:30 a.m. a fire started at the Internet Archive’s San Francisco scanning center.

Good news:

no one was hurt and no data was lost. Our main building was not affected except for damage to one electrical run. This power issue caused us to lose power to some servers for a while.

Bad news:

Some physical materials were in the scanning center because they were being digitized, but most were in a separate locked room or in our physical archive and were not lost. Of those materials we did unfortunately lose, about half had already been digitized. We are working with our library partners now to assess.

That loss is unfortunate, but imagine if the fire had been in the main server room holding the Internet Archive’s 2 petabytes of data. Wisely, the project has placed copies at other locations …

That’s good to know, but it seems rather foolish for the world to depend on the Internet Archive always being able to keep all its copies up to date, especially as the quantity of data that it stores continues to rise. This digital library is so important in historical and cultural terms: surely it’s time to start mirroring the Internet Archive around the world in many locations, with direct and sustained support from multiple governments.

In addition to the issue of vulnerability, there’s also the issue of authenticity, from my June 5, 2013 posting about science, archives and memories,

… Luciana Duranti [Professor and Chair, MAS {Master of Archival Studies}Program at the University of British Columbia and Director, InterPARES] and her talk titled, Trust and Authenticity in the Digital Environment: An Increasingly Cloudy Issue, which took place in Vancouver (Canada) last year (mentioned in my May 18, 2012 posting).

Duranti raised many, many issues that most of us don’t consider when we blithely store information in the ‘cloud’ or create blogs that turn out to be repositories of a sort (and then don’t know what to do with them; ça c’est moi). She also previewed a Sept. 26 – 28, 2013 conference to be hosted in Vancouver by UNESCO (United Nations Educational, Scientific, and Cultural Organization), “Memory of the World in the Digital Age: Digitization and Preservation.” (UNESCO’s Memory of the World programme hosts a number of these themed conferences and workshops.)

The Sept. 2013 UNESCO ‘memory of the world’ conference in Vancouver seems rather timely in retrospect. The Council of Canadian Academies (CCA) announced that Dr. Doug Owram would be chairing their Memory Institutions and the Digital Revolution assessment (mentioned in my Feb. 22, 2013 posting; scroll down 80% of the way) and, after checking recently, I noticed that the Expert Panel has been assembled and it includes Duranti. Here’s the assessment description from the CCA’s ‘memory institutions’ webpage,

Library and Archives Canada has asked the Council of Canadian Academies to assess how memory institutions, which include archives, libraries, museums, and other cultural institutions, can embrace the opportunities and challenges of the changing ways in which Canadians are communicating and working in the digital age.

Background

Over the past three decades, Canadians have seen a dramatic transformation in both personal and professional forms of communication due to new technologies. Where the early personal computer and word-processing systems were largely used and understood as extensions of the typewriter, advances in technology since the 1980s have enabled people to adopt different approaches to communicating and documenting their lives, culture, and work. Increased computing power, inexpensive electronic storage, and the widespread adoption of broadband computer networks have thrust methods of communication far ahead of our ability to grasp the implications of these advances.

These trends present both significant challenges and opportunities for traditional memory institutions as they work towards ensuring that valuable information is safeguarded and maintained for the long term and for the benefit of future generations. It requires that they keep track of new types of records that may be of future cultural significance, and of any changes in how decisions are being documented. As part of this assessment, the Council’s expert panel will examine the evidence as it relates to emerging trends, international best practices in archiving, and strengths and weaknesses in how Canada’s memory institutions are responding to these opportunities and challenges. Once complete, this assessment will provide an in-depth and balanced report that will support Library and Archives Canada and other memory institutions as they consider how best to manage and preserve the mass quantity of communications records generated as a result of new and emerging technologies.

The Council’s assessment is running concurrently with the Royal Society of Canada’s expert panel assessment on Libraries and Archives in 21st century Canada. Though similar in subject matter, these assessments have a different focus and follow a different process. The Council’s assessment is concerned foremost with opportunities and challenges for memory institutions as they adapt to a rapidly changing digital environment. In navigating these issues, the Council will draw on a highly qualified and multidisciplinary expert panel to undertake a rigorous assessment of the evidence and of significant international trends in policy and technology now underway. The final report will provide Canadians, policy-makers, and decision-makers with the evidence and information needed to consider policy directions. In contrast, the RSC panel focuses on the status and future of libraries and archives, and will draw upon a public engagement process.

So, the government is shutting down libraries in order to save money and they’re praying (?) that the materials have been digitized and adequate care has been taken to ensure that they will not be lost in some disaster or other. Meanwhile the Council of Canadian Academies is conducting an assessment of memory institutions in the digital age. The approach seems to backwards.

On a more amusing note, Rick Mercer parodies at lease one way scientists are finding to circumvent the cost-cutting exercise in an excerpt (approximately 1 min.)  from his Jan. 29, 2014 Rick Mercer Report telecast (thanks Roz),

Mercer’s comment about sports and Canada’s Prime Minister, Stephen Harper’s preferences is a reference to Harper’s expressed desire to write a book about hockey and possibly a veiled reference to Harper’s successful move to prorogue parliament during the 2010 Winter Olympic games in Vancouver in what many observers suggested was a strategy allowing Harper to attend the games at his leisure.

Whether or not you agree with the decision to shutdown some libraries, the implementation seems to have been a remarkably sloppy affair.

Canada-US Regulatory Cooperation Council’s Nanotechnology Work Plan

Thanks for Lynn L. Bergeson for her Dec. 1, 2012 posting on the Nanotechnology Now website for the information about a Nov. 28, 2012 webinar that was held to discuss a Nanotechnology Work Plan developed by the joint Canada-US Regulatory Cooperation Council (or sometimes it’s called the US-Canada Regulatory Cooperation Council),

The RCC requested that industry provide more information on the commercial distribution of nanomaterials, as well as more transparency by claiming confidentiality of only that information absolutely critical to market advantage.

To compare risk assessment and risk management practices to highlight and identify best practices, data gaps, and differences between the two jurisdictions, the RCC sought nominations of a nanomaterial substance for a case study. Four nanomaterial substances were nominated: multiwall carbon nanotubes, nanocrystalline cellulose, nano silver, and titanium dioxide. The RCC has selected multiwall carbon nanotubes for the case study. The RCC intends to hold in March 2013 a workshop in Washington, D.C., to discuss information collected to date and approaches moving forward. In spring 2013, the RCC will hold one or two conference calls or webinars to discuss information gathered between countries and the path forward. Finally, in fall 2013, the RCC expects to hold a stakeholder consultation/workshop on results to date.

Here’s some background on the RCC. First announced in February 2011, the RCC had its first ‘stakeholder’ session (attended by approximately 240)  in January 2012 in Washington, DC. where a series of initiatives, including nanotechnology, were discussed (from the US International Trade Administration RCC Stakeholder Outreach webpage),

Agriculture and Food, Session A

  • Perimeter approach to plant protection

Agriculture and Food, Session B

  • Crop protection products

Agriculture and Food, Session C

  • Meat/poultry – equivalency
  • Meat/poultry – certification requirements
  • Meat cut nomenclature

Agriculture and Food, Session D

  • Veterinary drugs
  • Zoning for foreign animal disease

Agriculture and Food, Session E

  • Financial protection to produce sellers

Agriculture and Food, Session F

  • Food safety – common approach
  • Food safety – testing

Road Transport – Motor Vehicles

  • Existing motor vehicle safety standards
  • New motor vehicle safety standards

Air Transport

  • Unmanned aircraft

Transportation

  • Intelligent Transportation Systems

Transportation

  • Dangerous goods means of transportation

Marine Transport

  • Safety and security framework & arrangement for the St. Lawrence Seaway & Great Lakes System
  • Marine transportation security regulations
  • Recreational boat manufacturing standards
  • Standard for lifejackets

Rail Transport

  • Locomotive Emissions
  • Rail Safety Standards

Environment

  • Emission standards for light-duty vehicles

Personal Care Products & Pharmaceuticals

  • Electronic submission gateway
  • Over-the-counter products – common monographs
  • Good manufacturing practices

Occupational Safety Issues

  • Classification & labelling of workplace hazardous chemicals

Nanotechnology

  • Nanotechnology

Led jointly by senior officials from Canada and the United States, the purpose of the various technical review sessions was to seek expert advice and technical input from the approximately 240 stakeholders in attendance.

Since the Jan. 2012 meeting, a Nanotechnology Work Plan has been developed and that’s what was recently discussed at the Nov. 28, 2012 webinar. I did find more on a Canadian government website, Canada’s Economic Action Plan Nanotechnology Work Plan webpage,

Nanotechnology Work Plan

 Canada Leads: Karen Dodds, Assistant Deputy Minister, Science and Technology Branch, Environment Canada (EC)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Health Canada (HC)

U.S. Lead: Margaret Malanoski, Office of Information and Regulatory Affairs, Office of Management and Budget

Deliverable Outcome: Share information and develop common approaches, to the extent possible, on foundational regulatory elements, including criteria for determining characteristics of concern/no concern, information gathering, approaches to risk assessment and management, etc. Develop joint initiatives to align regulatory approaches in specific areas such that consistency exists for consumers and industry in Canada and the US.

Principles: Identification of common principles for the regulation of nanomaterials to help ensure consistency for industry and consumers in both countries

3-6 months:

Canada provides initial feedback on US “Policy Principles for the US Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials”.

6-12 months:

Countries complete an initial draft of shared principles for the regulation of nanomaterials.

12-18 months:

Update of draft principles informed from on-going stakeholder and expert consultations.

18th month:

Stakeholder consultation / workshop on results to date and future ongoing engagement.

Beyond 18 months:

Countries complete final draft of shared principles for the regulation of nanomaterials.

Workplan for Industrial Nanomaterials

Priority-Setting: Identify common criteria for determining characteristics of industrial nanomaterials of concern/no-concern

1-3 months:

  1. Define and finalize workplan (1st month)
  2. Develop mechanisms for stakeholder outreach and engagement (1st month)
  3. Conference call with relevant stakeholders to share and discuss workplan and call for Industry to volunteer nanomaterials for joint CAN/US review

3-6 months:

Share available scientific evidence regarding characteristics of industrial nanomaterials including that obtained from existing international fora (e.g. OECD Working Party on Manufactured Nanomaterials [Canada is a lead in the OECD Working Party on Manufactured Nanomaterials]).

8th month:

Stakeholder workshop to discuss information collected to date and approaches moving forward.

6-12 months:

Initiate an analysis of characteristics of select nanomaterials: similarities, differences, reasons for them.

Initiate discussions on approaches to consider for common definitions and terminology.

12th month:

Second conference call with relevant stakeholders to discuss non-CBI information gathered between the Countries and to discuss path forward in terms of development of reports and analyses.

12-18 months:

Develop draft criteria for determining characteristics of industrial nanomaterials of concern/no-concern.

15th month:

Third conference call with relevant stakeholders to discuss progress and to prepare for the upcoming stakeholder consultation/workshop.

Here’s information for the leads should you feel compelled to make contact,

Canada

(Lead) Karen Dodds, Assistant Deputy Minister, Science and Technology, Environment Canada ([email protected]; ph. 613- 819-934-6851)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch ([email protected]; ph. 613-946-6701)

United States

(Lead) Margaret Malanoski, Office of Management and Budget ([email protected])

I gather that the ‘stakeholders’ are business people, researchers, and policy analysts/makers as there doesn’t seem to be any mechanism for public consultation or education, for that matter.

A new standard (in Canada) for occupational exposure to engineered nanomaterials

The Oct. 31, 2012 announcement from the CSA (Canadian Standards Association?) Group (H/T to the Canadian Safety Reporter) is a bit skimpy on details but here goes,

CSA Group, a leading standards development, testing and certification organization officially announces Canada’s first adopted International Organization for Standardization (ISO) standard on nanotechnologies. CSA Z12885, Nanotechnologies – Exposure control program for engineered nanomaterials in occupational settings provides guidance for the safe use of nanomaterials in the workplace.

“The development of standards is crucial for effective and responsible commercialization of nanotechnologies,” said Brian Haydon, Senior Project Manager, Standards, CSA Group. “CSA Z12885 is the first in a series of standards on nanotechnologies being adopted in Canada, resulting from international and Canadian contributions to the continued activity of ISO/TC 229, the ISO Technical Committee on nanotechnologies.”

CSA Z12885, Nanotechnologies – Exposure control program for engineered nanomaterials in occupational settings provides guidance to establish and implement a comprehensive managed program to control exposure to nanomaterials in the workplace. This follows recognized approaches to risk management with a focus on information and issues specific to nanotechnologies including hazard identification, risk assessment procedures, training requirements and worker engagement. CSA Z12885 contains revisions to ISO/TR 12885 and additional guidance to reflect Canadian practices and safety considerations.

It’s interesting to note which agencies offered financial support to develop this CSA Z12885 standard,

This standard was announced to industry and research stakeholders at the recent Nano Ontario 2012 Conference in Waterloo, Ontario, Canada. The development of this Standard was made possible, in part, by the financial support of Alberta Innovates Technology Futures – nanoAlberta, Health Canada, MDEIE (Developpement economique, Innovation et Exportation – Gouvernement du Quebec) and the National Research Council Canada – Industrial Research Assistance Program.

I first mentioned this standard in my June 12, 2012 posting about the OECD (Organization for Economic Cooperation and Development) and Canada’s report regarding its nanotechnology initiatives,

4. Information on any Developments Related to Good Practice Documents.

A. The Canadian Standards Association (CSA) Technical Committee on Nanotechnologies – Occupational Health and Safety has completed a draft national standard (CSA Z12885) to provide guidance for workers, entitled “Nanotechnologies — Exposure control program for engineered nanomaterials in occupational settings” This document is largely based on the published international ISO Technical Report, ISO/TR 12885:2008 entitled “Health & Safety Practices in Occupational Settings relevant to Nanotechnologies”. The CSA Z12885 standard has completed the public review process and is proceeding to ballot, with completion anticipated in mid-2012.

B. Government, industry, research, user, and consumer interests are participating as designated experts from Canada on international standards development through the Canadian Advisory Committee to International Organization for Standardization/Technical Committee 229 (ISO/TC229) Nanotechnologies, facilitated by CSA Standards. This includes active participation on terminology, nomenclature, measurement, characterization, material specification and health, safety, environmental aspects of nanotechnologies standards under development.

They’ve been working on this standard for at least two years as I first mentioned it in a Sept. 24, 2012 posting about earlier OECD report on Canada’s nanotechnology initiatives.

TAPPI 2012 nanotechnology conference in Canada

This coming Monday, June 4 to Thursday, June 7, 2012, the Nanotechnology for Renewable Materials conference (2012 TAPPI [Technical Association of the Pulp and Paper Industry] International Conference) will be taking place in Montréal, Québec.

As one might expect, there’s going to be a major emphasis on nanocrystalline cellulose (NCC) and Celluforce’s new NCC production plant in Windsor, Québec. Keynote speakers for the conference include (from the Keynote Speakers webpage),

Dr. Dylan J. Boday
Advisory Engineer Team Lead
IBM’s Materials Engineering Laboratory

Dr. Dylan J. Boday is the Advisory Engineer Team Lead for IBM’s Materials Engineering Laboratory. In this role, he leads efforts across multiple divisions to advance technological capabilities and enhance product performance.

Dylan’s research at IBM focuses on creating inventive pathways toward the development of polymers, composites, surface science, nanoparticles and hybrid materials. He has organized several strategic partnerships to leverage new materials development that align with specific business needs for IBM. He also established and now leads a global team focused on the sustainability of IBM’s products and is the co-lead of an upcoming international conference that will focus on the advances and challenges of sustainable materials.

As a member of the American Chemical Society Polymer Board, he provides leadership to the broader polymer science field. His technical contributions have led to more than 30 patent filings in the areas of electrostatic discharge and thermally conductive composites, functional nanomaterials and printed circuit board materials. He also has numerous published articles on composites, self healing materials and anti-corrosion coatings, in addition to serving as a reviewer for several scientific journals. In 2011, he was named an IBM Master Inventor and is a member of the IBM Smarter Planet invention review board.

Dylan holds a bachelor’s degree in Chemistry and a doctorate degree in Materials Engineering from the University of Arizona.

Jean Moreau
President and Chief Executive Officer
CelluForce

As President and CEO of CelluForce since February 2011, Jean Moreau brings a wealth of experience in finance, operations and business development which he acquired in both private and public corporations, in various fields including manufacturing, entertainment, distribution and consumer goods.

A chartered accountant for over 10 years at Arthur Andersen and Co., Mr. Moreau was responsible for the acquisition of numerous large companies and plants.

Among others, he headed financial and production planning teams as Vice President of Finance, Paper Production sector and Vice President of Supply for Domtar. As Chief Financial Officer, he was also involved in the introduction of the Supremex Income Fund on the Toronto Stock Exchange, raising $300M in capital funding and, in addition was responsible for the implementation of a strategic business plan at Guess Canada, which was subsequently named one of Canada’s 50 Best Managed Companies.

As head of the CelluForce team, Jean wished to promote, within several sectors of activity, the development of commercial applications related to NCC around the world, thus ensuring the company’s manufacturing and commercial growth.

Jean Hamel, Eng.
Vice President
FPInnovations

Jean Hamel, Eng., Vice President, FPInnovations, received his B.Sc. (1983), and M. Eng. (1985), in Mechanical Engineering from the University of Sherbrooke. He joined Pulp and Paper Research Institute of Canada (Paprican) as a Research Engineer to work on the technical development, optimization and troubleshooting of paper finishing equipment.

In 1995 he joined St-Laurent Paperboard as a Senior Process Engineer to work on product development, paper machine optimization and start-up of new finishing equipment. In 1996, he returned to Paprican where he led the construction of the pilot paper machine and developed the new Roll Testing Facility, the first business unit concept of the organization. In 2004 he became Manager of the Product Performance Program. Soon after merging of three research institutes (Paprican, Forintek, FERIC) to form FPInnovations in 2007, he was named the Director of Research for the Pulp & Paper Division of FPInnovations where he focused on accelerating the technology transfer and developing new innovation processes.

Since 2009 he has been the Vice President of FPInnovations, leading the innovation program on pulp and paper and shifting the R&D effort to develop new chemicals, biomaterials and composites from wood fibers. He currently sits on the boards of CelluForce, a Domtar-FPInnovations joint venture on nanocrystalline cellulose (NCC) production, Sustainable Chemistry Alliance (SCA), ICGQ, ADRIQ and NSERC Green Fiber Network.

Andy Atkinson
Manager, Emerging Sciences Policy
Policy, Planning and Coordination Division
Strategic Policy Branch
Health Canada

Andrew Atkinson is currently Manager of the Emerging Science Policy group under the Strategic Policy Branch of Health Canada.

Andrew is currently overseeing coordination of science policy issues across the various regulatory and research programs under the mandate of Health Canada. Prior to Health Canada, he was a manager under Environment Canada’s CEPA new chemicals program, where he oversaw chemical and nanomaterial risk assessments, as well as the development of risk assessment methodologies.

In parallel to domestic work, he has been actively engaged in ISO and OECD nanotechnology efforts, including co-chairing groups on nomenclature of nano-objects under ISO TC229.

It seems more heavily weighted towards Canadian keynote speakers with, as I hinted earlier,  a special nod to CelluForce. I did glance through the full conference programme and see that there is  healthy representation internationally (Hungary, China, Finland, US, Sweden, Japan, Alberta [sometimes that province does seem like a separate country],  etc.).

After hearing a murmur about developing standards for nanocellulose at the Feb. 2012 annual meeting of the American Association for Advancement of Science (AAAS), I was excited to find this on on p. 8 of the conference programme,

The success of the 2011 Workshop on International Standards for Nancellulose has resulted in writing of the Roadmap for the Development of International Standards for Nanocellulose (Draft 4). Since then TAPPI has formed the International Nanocellulose Standards Coordination Committee (INSCC) in its Nanotechnology Division to house and coordinate the execution of the Roadmap. The 2012 Workshop on International Standards for Nancellulose will bring workshop participants up-to-date on nanocellulose standards activities since the completion of the Roadmap (Draft 4), initiate coordination activities in several areas of nanocellulose standards development, and if necessary, discuss revisions to the Roadmap.

Perhaps one of these days they’ll have a final version of their Roadmap.

I last mentioned this annual conference in my Sept. 24, 2009 posting when it was held in Alberta and made passing references to the 2010 edition in Finland during an interview (my Aug. 27, 2010 posting) with Dr. Richard Berry of FPInnovations and to the 2011 edition in Washington, DC in my June 6, 2011 posting about the formation, by Domtar and FPInnovations, of CelluForce.

As for the 2012 edition, I wonder if they considered inviting Janelle Tam, the 16 year old student who won a national award for her work on a new application for NCC (my Disease-fighting and anti-aging with nanocrystalline cellulose (NCC) and Janelle Tam posting on May 11, 2012) to this conference. In any event, her national win entitled her to compete for an international award in Boston, Massachusetts June 18, 2012.

Nanoparticle size doesn’t matter

Does size matter when regulating nanomaterials? As I’ve noted (more than once), I waffle on this issue. Earlier this week, I featured my thoughts on Health Canada’s definition of nanomaterial (Oct. 24, 2011)  and posted an interview with Dr. Andrew Maynard (Oct. 24, 2011) where he expressed reservations about basing nanomaterial regulations on definitions which rely on  nanoparticle size.

Hours after posting my thoughts and the interview with Andrew, I came across this Oct. 24, 2011 news item on Nanowerk titled, Nanoparticles and their size may not be big issues. From the news item,

If you’ve ever eaten from silverware or worn copper jewelry, you’ve been in a perfect storm in which nanoparticles were dropped into the environment, say scientists at the University of Oregon.

Since the emergence of nanotechnology, researchers, regulators and the public have been concerned that the potential toxicity of nano-sized products might threaten human health by way of environmental exposure.

Now, with the help of high-powered transmission electron microscopes, chemists captured never-before-seen views of miniscule metal nanoparticles naturally being created by silver articles such as wire, jewelry and eating utensils in contact with other surfaces. It turns out, researchers say, nanoparticles have been in contact with humans for a long, long time. [emphasis mine]

“Our findings show that nanoparticle ‘size’ may not be static, especially when particles are on surfaces. For this reason, we believe that environmental health and safety concerns should not be defined — or regulated — based upon size,” said James E. Hutchison, who holds the Lokey-Harrington Chair in Chemistry. [emphasis mine] “In addition, the generation of nanoparticles from objects that humans have contacted for millennia suggests that humans have been exposed to these nanoparticles throughout time. Rather than raise concern, I think this suggests that we would have already linked exposure to these materials to health hazards if there were any.”

This discussion is becoming quite interesting.

My thoughts on the Health Canada nanomaterial definition

In my Oct. 11, 2011 posting, I noted that Health Canada had released both its nanomaterial definition and its response to the public consultation that took place in 2010. Unfortunately, it’ s not possible to attempt the same sort of  analysis (mentioned in my Oct. 21, 2011 posting) that Dr. Andrew Maynard applied to the US government (National Nanotechnology Initiative) public consultation on EHS (environmental, health and safety) research strategy as Health Canada did not make the submissions available for viewing.

In my first posting, I focused largely on the public consultation aspects, now I’d like to look more closely at the definition itself (especially in the wake of the European Commission’s Oct. 19, 2011 announcement of its nanomaterials definition). Note: Health Canada says nanomaterial; European Commission says nanomaterials.

Here’s the definition (from the Policy Statement on Health Canada’s Working Definition for Nanomaterial webpage),

4.1 Health Canada’s Working Definition of Nanomaterial

Health Canada considers any manufactured substance or product and any component material, ingredient, device, or structure to be nanomaterial if:

  1. It is at or within the nanoscale in at least one external dimension, or has internal or surface structure at the nanoscale, or;
  2. It is smaller or larger than the nanoscale in all dimensions and exhibits one or more nanoscale properties/phenomena.

For the purposes of this definition:

  1. The term “nanoscale” means 1 to 100 nanometres, inclusive;
  2. The term “nanoscale properties/phenomena” means properties which are attributable to size and their effects; these properties are distinguishable from the chemical or physical properties of individual atoms, individual molecules and bulk material; and,
  3. The term “manufactured” includes engineering processes and the control of matter.

4.2 Elaboration

The Working Definition is not an additional source of authority, but works within the existing regulatory frameworks that allow for obtaining information.

Information is submitted to Health Canada regulatory programs as required by legislation and their associated regulations. Within these legislative and regulatory frameworks, Health Canada may request specific information (see Section 6) for a regulated substance or product that is, or contains, a nanomaterial as described in the Working Definition.

The term “manufactured” includes engineering processes and control of matter that lead to the synthesis, generation, fabrication or isolation of nanomaterials. Health Canada may request information regarding a deliberately or incidentally manufactured nanomaterial for risk assessment purposes. This term also includes natural components that have been deliberately used or engineered to have nanoscale properties/phenomena, used in nanoscale encapsulation of bioactive compounds, or used in tissue engineering.

“Part a” of the Working Definition relates to current evidence suggesting that nanoscale properties/phenomena are more likely observable at the scale of 1-100 nanometres (more often at the lower end) and “Part b” reflects that it is possible for nanoscale properties/ phenomena to be exhibited outside this size range, such as select quantum devices.

A variety of lexicons and interpretations of “nano-terminology” currently exist, underlining the importance of understanding the context in which these terms are used. In the risk assessment context supporting hazard and exposure assessment for risk characterization and management, the term “nanoscale properties/phenomena” refers to size-related properties which have qualities or characteristics that do not readily extrapolate from those observed in individual atoms, molecules or bulk materials. For example, “bulk” gold is not very reactive, but nanoscale gold can act as a chemical catalyst. For risk assessment purposes, this term includes observable biological or environmental effects resulting from size-related properties as described above. Examples of such biological or environmental effects could be increased permeability through cell membranes or increased reactivity of iron/iron oxides for the purposes of groundwater remediation, respectively.

Internal or surface structures at the nanoscale include nanomaterials that are aggregated or agglomerated to form a larger group. While the break-up of aggregates is less likely, a larger group could be broken down into component nanomaterials in the human body or the environment. Some regulatory programs may request information above the 100 nm size range to an upper limit of 1000 nm in order maintain flexibility to assess potential nanomaterials, including suspected nanoscale properties/phenomena. The 1000 nm cut-off attempts to separate characteristics attributable to macro-scaled materials from those of nanomaterials. However, a product or substance that contains nanomaterial could measure beyond 1 micron in size (for example (e.g.) bundles of carbon nanotubes that are very long). In these cases, regardless of the size, information may be requested for risk assessment purposes.

In addition to requesting information about nanomaterials, information regarding particles above the 100 nm size range may also be requested by some regulatory programs to assess possible biological effects that could be attributable to their dimension or size. These approaches may be applied on a case-by-case basis or to a whole product class.

While not expressly stated in the Working Definition, information regarding nanomaterial size distribution, especially number size distribution, is also relevant for risk assessment purposes.

Currently, there is insufficient evidence to establish common threshold values for size distributions of relevance across all substances and product lines that Health Canada regulates.

I find the fact that this is called a ‘working’ definition immediately establishes a very different frame of reference as the term ‘working’ in this context suggests flexibility. like a ‘working’ hypothesis which can by redefined as more information becomes available. You can find a longer definition for working hypothesis in this Wikipedia essay.

The first two items in the definition are very generalized (in fact, downright vague) but this changes when the meaning of the terms are described where everything becomes more specific. It’s only when reading the elaboration that one realizes how very carefully this definition has been constructed. They have given themselves a lot of ‘wiggle room’. For example,  “”Part a” of the Working Definition relates to current evidence suggesting that nanoscale properties/phenomena are more likely observable at the scale of 1-100 nanometres (more often at the lower end) and “Part b” reflects that it is possible for nanoscale properties/ phenomena to be exhibited outside this size range, such as select quantum devices.”  [emphasis mine]

I’m still waffling as to whether or not a definition is necessary although I’m inclined to say yes to a definition when I see something like this. I think a good balance has been struck between caution and unnecessary (at this time) regulation. E.g., ” Currently, there is insufficient evidence to establish common threshold values for size distributions of relevance across all substances and product lines that Health Canada regulates.” [emphasis mine]

The French and others weigh in on the European nanomaterials definition (included here)

The responses to the announcement of the nanomaterials definition for Europe are coming fast and furious now. A summary from L’Association de Veille et d’Information Civique sur les Enjeux des Nanosciences et des Nanotechnologies (L’Avicenn) is available in an Oct. 20, 2011 news item on Nanowerk (French language version is available here),

Avicenn offers a first insight into the politics hidden behind this supposedly neutral and “scientific” definition, the next obstacles and important meetings, and then concludes on the suspense surrounding the definition that France will finally adopt for the annual mandatory declaration of nanomaterials it is implementing.

In a self-applauding press release, the European Commission announced yesterday that it finally published “a clear definition (of nanomaterials) to ensure that the appropriate chemical safety rules apply”. Nanomaterial is defined as:

  • “a natural, incidental or manufactured material
  • containing particles, in an unbound state or as an aggregate or as an agglomerate
  • and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm – 100 nm.”

Here’s a list of the responding organizations (from the Oct. 20, 2011 news item on Nanowerk),

After the release of this new definition, the most active “stakeholders” have already formally responded: among them, on the side of CSOs, the European Environmental Bureau (BEE) – the federation of 140+ environmental organisations in 31 countries, Friends of the Earth Australia (FoE Australia), the Center for International Environmental Law (CIEL), the European Consumers’ Organisation (BEUC) or the European consumer voice in standardisation (ANEC); on the industrial side, the European Chemical Industry Council (CEFIC).

I posted European nanomaterials definition not good enough about the response from the European Environmental Bureau yesterday (Oct. 19, 2011). So this may seem mildly repetitive (from English language tranaslation on the Avicenn website),

  • The new 100 nm upper limit

Friends of the Earth Australia, ANEC and BEUC denounce the adoption of the upper limit of 100 nm that they consider too restrictive: these CSOs would have preferred a higher threshold limit, that would have encompassed more materials. They refer to the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)’s highlight of the lack of scientific basis for this 100nm limit, and to results of toxicology studies on toxicity of submicron particles over 100 nm.
As illustrated by Foe Australia, “if this definition were applied to regulation, it would mean that where 45% of particles are 95nm in size and 55% particles are 105nm in size, substances would not be regulated as nano”at the expense of consumers and workers exposed to these substances and over whom will therefore keep hanging the threat of a risk that is assumed but not evaluated.
In response to EC consultation on its draft definition in 2010, many CSOs [civil society organizations] had argued for a threshold of 300 nm.
FoE Australia alerts to the fact that “some European cosmetics companies and North American bioactive manufacturers are reformulating their products to exploit the novel optical, chemical and biological properties of larger nanomaterials (ie >100nm) while escaping the labelling and safety assessment requirements that were anticipated for materials 1-100nm in size”.

  • 50% threshold

Some organizations – including CIEL and ANEC – applaud the choice of particle number (i.e. the number of particles) rather than mass as a measuring unit for size distribution of a nanomaterial product ; in contrast, CEFIC (which had strongly advocated using weight concentration rather than particle number distribution to determine the cut-off criterion for nanomaterials) is concerned that the adoption of this definition will add unnecessary burden for companies, leading to added costs and less efficient use of resources. The Commission followed by the recommendations of SCENIHR, which had been particularly supported by ANEC in 2010.
The Commission, however, largely raised the proportion of nano-sized materials required to qualify as nanomaterial compared to what was expected: 50% or more of the particles in the number size distribution is 50 times higher than the one that was proposed by DG Environment and supported by civil society (1%) and 333 times greater than that recommended by SCENIHR (0.15%) and supported by DG Sanco.
CSOs have expressed their surprise, incomprehension and hostility to such a high threshold. For example CIEL pinpoints that even the German industry had not been so demanding: it had campaigned for a rate of 10% “only”. However, the Commission provided that “in specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %”. While CIEL or ClientEarth welcome this opportunity, FoE Australia deplores that it puts a huge burden of proof on to the CSOs to demonstrate not only that certain nanomaterials can cause harm but that certain they do so as a specific proportion of particles in a sample. Showing that some nanomaterials can cause damage in itself is already very difficult by the uncertainties, the gaps in the safety science, the variability of nanomaterials and the lack of information about real life exposure. But making the same demonstration by identifying the fraction of nanoparticles in a sample that cause such harm is even more difficult, actually well beyond current scientific knowledge.

  • The inclusion of aggregate and agglomerate

CIEL appreciates the inclusion of aggregate and agglomerate within the definition. CEFIC believes that this measure will make any European legislation on nanomaterials too restrictive.

The apparent technical nature of these debates and, ultimately, the arbitrary selection of thresholds illustrate the strong political dimension at work behind the decisions made by the EC : granted, the European authorities have had to make a decision based on “sound science” – backed by consultation of scientific experts – but in the end, they mainly had to come up with a trade-off between conflicting interests of stakeholders.

Here’s how they hope the French government will respond to all of this (from the English translation on the Avicenn website),

As far as France is concerned, it is not clear at present whether the decree on the annual declaration of “substances with nanoparticle status” will use the new definition of the European Commission. In its decree, the French government might try to maintain a larger definition than the definition adopted by the Commission. CSOs are turning with hope towards French choice which will be determinant for the future: if the adopted definition is larger than that of the Commission and therefore more in line with the precautionary principle, it could serve as an example and be followed in other countries.

For anyone who may not be familiar with some recent French nanotechnology history, in the Spring of 2010 there were major nanotechnology protests in France during a series of public debates.  You can read more about them in my Jan. 26, 2011 posting, Feb. 26, 2010 posting, and followup March 10 , 2010 posting, which includes details about a French-language podcast with two Québec academics discussing the French protests.

This does clear up one question I had about European Commission (EC) jurisdictions and national jurisdictions. It seems that countries can choose to create their own definitions although I imagine they cannot be at cross-purposes with the EC definition.

On an almost final note, here’s Dexter Johnson (Nanoclast blog for the Institute of Electrical and Electronics Engineers [IEEE]) in his Oct. 19, 2011 posting,

The definition itself…well, I don’t see how it helps to narrow anything, which I understand to be one of the main purposes of definitions. It would seem that the nanoparticles that are given off when your car’s tires roll along the pavement are now up for regulatory policy (“Nanomaterial” means a natural, incidental or manufactured material containing particles…”). And due to the lack of distinction between “hard” and “soft” nanoparticles in the definition, Andrew Maynard points out that “someone needs to check the micelle size distribution in homogenized milk.”

So what is the fallout from this definition? It would seem to be somewhat less than had been anticipated earlier in the year when worries surrounded getting the definition just right because it would immediately dictate policy.

So basically they have created a class of materials that at the moment are not known to be intrinsically hazardous, but if someday they are they now have a separate class for them. While some may see as this as making some sense, it eludes me.

As for me, I think much depends on future implementations. After all, you can have the best system possible but if it’s being run by fools, you have a big problem. That said, I take Dexter’s point about establishing a class of materials ‘just in case there could be a problem’. I really must take another look at the Health Canada nanomaterials definition.

Note: I removed footnotes from the Avicenn material; these can easily be found by viewing either the Oct. 20, 2011 news item on Nanowerk or the material on the Avicenn site.

ETA Oct. 20, 2011 1500 hours: I forgot to include a link to the ANEC response in this Oct. 20, 2011 news item on Nanowerk.